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NCT04024943 · ClinicalTrials.gov registry record
Personalized Therapy Study - Attain Stability Quad Post-Approval Study
A clinical trial of Heart Failure, sponsored by Medtronic.
- Active
- Registry status
- 1,092
- Enrollment target
- 20
- Study locations
NCT04024943: Active study of Heart Failure, sponsored by Medtronic.
NCT04024943 is a study of Heart Failure that is active but no longer recruiting, run by Medtronic. The registered enrollment target is 1,092 participants, below the 2,046-participant average among 397 other Heart Failure trials with a reported enrollment target (47% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04024943, a study of Heart Failure, is active but no longer recruiting, sponsored by Medtronic.
- ACTIVE NOT RECRUITING
- Registry status
- 1,092 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this Post-Approval Study (PAS) is to evaluate the long-term performance of the Model 4798 Left Ventricular (LV) lead in a real-world patient population. Patients will be followed for the duration of the PAS. This study is required by FDA as a condition of approval of the Model 4798 LV lead and is integrated within the Product Surveillance Registry (PSR).
Primary Outcome
To demonstrate that the complication-free probability is greater than 92.5% at five years post-implant for Attain Stability Quad LV leads.
Conditions Studied
Interventions
- DEVICE Quadripolar LV Lead
Study Locations (20)
Florida
- Clearwater Cardiovascular Consultants - Clearwater
- Heart Rhythm Solutions - Hollywood
- Baptist Health - Jacksonville
- Cardiovascular Institute of Northwest Florida - Panama City
- Heart & Vascular Institute of Florida - Safety Harbor
- Heart Rhythm Consultants P.A. (Sarasota Memorial Research) - Sarasota
California
- Chula Vista Cardiac Center - Chula Vista
- San Diego Arrhythmia Associates - San Diego
- COR Healthcare - Torrance
- Cardiovascular Consultants Medical Group (Van Nuys) - Van Nuys
- Cardiology Associates Medical Group - Ventura
Colorado
- Colorado Springs Cardiology - Colorado Springs
- Denver Heart - Denver
- Colorado Heart and Vascular - Lakewood
Arkansas
- Cardiology Associates of Northeast Arkansas - Jonesboro
- Saint Vincent Heart Clinic Arkansas - Little Rock
Connecticut
- Hartford Hospital - Hartford
- Yale New Haven Hospital - New Haven
Alaska
- Alaska Heart - Anchorage
Arizona
- Southwest EP - Chandler
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,092 participants |
| Start Date | 2017-08-21 |
| Est. Completion | 2028-01 |
What the registry record for NCT04024943 still lists
NCT04024943 is an observational study that tracks outcomes without assigning an intervention. Its 1,092 participants enrollment target places it among the larger protocols in the corpus, below the 2,046-participant average among 397 other Heart Failure trials with a reported enrollment target (47% lower).
The record links to 1 condition, with Heart Failure appearing as the primary indexed condition, and to 1 intervention - of which Quadripolar LV Lead is the first listed.
NCT04024943 names 20 study sites across 7 states, led by Florida, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT04024943 about?
NCT04024943 is a clinical study titled "Personalized Therapy Study - Attain Stability Quad Post-Approval Study". The purpose of this Post-Approval Study (PAS) is to evaluate the long-term performance of the Model 4798 Left Ventricular (LV) lead in a real-world patient population. Patients will be followed for the duration of the PAS. This study is required by FDA as a condition of approval of the Model 4798 LV...
What is the current status of trial NCT04024943?
This trial is currently active not recruiting. The enrollment target is 1,092 participants. The study started on 2017-08-21. Estimated completion is 2028-01.
What conditions does trial NCT04024943 study?
This clinical trial studies the following conditions: Heart Failure.
What interventions are being tested in trial NCT04024943?
The interventions under investigation include: Quadripolar LV Lead (DEVICE).
Who is sponsoring clinical trial NCT04024943?
This trial is sponsored by Medtronic, which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04024943 being conducted?
This trial has 20 study locations across Alaska, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Heart Failure
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04024943's enrollment target sits among peer trials
1,092 66th of 397 higher than 332 of 397 other Heart Failure trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Heart Failure trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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